Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
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| ClinicalTrials.gov Identifier: NCT01582672 |
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Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : April 23, 2012
Last Update Posted : June 14, 2018
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Sponsor:
Argos Therapeutics
Information provided by (Responsible Party):
Argos Therapeutics
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Brief Summary:
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Renal Cell Carcinoma Renal Cell Carcinoma Metastatic Renal Cell Carcinoma | Drug: Standard Treatment Biological: AGS-003 | Phase 3 |
This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 462 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) |
| Study Start Date : | November 2012 |
| Actual Primary Completion Date : | April 2018 |
| Actual Study Completion Date : | April 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sunitinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
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Biological: AGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters. |
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Active Comparator: Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
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Drug: Standard Treatment
Standard treatment for Renal Cell Carcinoma
Other Name: Sunitinib |
Primary Outcome Measures :
- Overall Survival [ Time Frame: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study ]Duration from randomization to death
Secondary Outcome Measures :
- Progression Free Survival [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
- Tumor Response [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.
- Monitor treatment emergent adverse events between both arms [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]Compare adverse events between both arms.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria for Tumor Collection:
- Diagnosis or clinical signs of advanced RCC
- Scheduled for cytoreductive or partial nephrectomy
Key Exclusion Criteria for Tumor Collection:
- Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions
- Requirement for systemic chronic immunosuppressive drugs or corticosteroids
- Evidence of brain metastases prior to nephrectomy
Key Inclusion Criteria for Treatment Study:
- Advanced disease, histologically assessed as RCC, with predominantly clear cell histology
- Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1
- Subjects who are candidates for standard first-line therapy initiating with sunitinib
- Time from diagnosis to treatment < 1 year
- Karnofsky performance status (KPS) ≥ 70%
- Life expectancy of 6 months or greater
- Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
- Adequate hematologic, renal, hepatic, and coagulation function
- Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
- Normal ECG or clinically non-significant finding(s) at Screening
- Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Key Exclusion Criteria for Treatment Study:
- Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
- Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
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Patients with 4 or more of the following risk factors:
- Hgb < LLN
- Corrected calcium > 10.0 mg/dL
- KPS < 80%
- Neutrophils > ULN
- Platelets > ULN
- Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)
- NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
- Clinically significant cardiovascular conditions within 3 months prior to Randomization
- Significant gastrointestinal abnormalities
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C
- Current treatment with an investigational therapy on another clinical trial
- Pregnancy or breastfeeding
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582672
Locations
Show 125 study locations
Sponsors and Collaborators
Argos Therapeutics
Investigators
| Principal Investigator: | Robert Figlin, MD, FACP | Cedars-Sinai Medical Center | |
| Principal Investigator: | Christopher G Wood, MD, FACP | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Argos Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01582672 |
| Other Study ID Numbers: |
AGS-003-007 2012-000871-17 ( EudraCT Number ) |
| First Posted: | April 23, 2012 Key Record Dates |
| Last Update Posted: | June 14, 2018 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Argos Therapeutics:
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RCC Kidney Cancer |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Kidney Diseases Urologic Diseases Male Urogenital Diseases Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |